Data / Medical devices / United States / Takeda Pharmaceuticals U.S.A., Inc.
Takeda Pharmaceuticals U.S.A., Inc.: FDA-registered device maker in Lexington, MA, United States, 4 510(k) clearances
Takeda Pharmaceuticals U.S.A., Inc. is registered with the FDA (registration 3016938816) in Lexington, MA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 29, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016938816
- Address
- 95 Hayden Avenue, Lexington, MA, United States, 02421
- Owner or operator
- Takeda Pharmaceuticals U.S.A., Inc. (10079762)
- Roles
- Specification developer
- First device listed
- December 22, 2020
- Registered through
- 2026
- Brand names listed
- Baxject II Hi-Flow Needleless Transfer Device, Baxject II Needleless Transfer Device, Cinryze, FlowEase Subcutaneous Infusion Set, Recombinant Factor VIII Substrate, Porcine Sequence
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Control, Plasma, Abnormal | GGC | 2 | Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Specification developer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 29, 2012 | K121092 | FLOWEASE [SUBCUTANEOUS] INFUSION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| October 30, 2009 | K092318 | BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE | LHI | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| October 8, 2004 | K042410 | BAXJECT II | LHI | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| July 29, 2003 | K031861 | MIX2VIAL TRANSFER DEVICE | LHI | Substantially Equivalent | Medimop Medical Projects, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, I.V. Fluid Transfer
- All makers of Set, Administration, Intravascular
- All makers of Control, Plasma, Abnormal
Updated June 29, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.